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Last Updated: May 18, 2025

CLINICAL TRIALS PROFILE FOR MEPRO-ASPIRIN


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505(b)(2) Clinical Trials for Mepro-aspirin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00011063 ↗ Effect of Ginkgo Biloba on Phenytoin Elimination Completed National Institutes of Health Clinical Center (CC) Phase 1 2001-02-01 This study will examine how the herbal remedy ginkgo biloba may affect the body's elimination of other medicines. Many people take ginkgo biloba to improve memory, mental alertness and overall feeling of well being. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between ginkgo biloba and other medications. This study will look at how ginkgo biloba affects the elimination of phenytoin-a medication used to treat patients with seizures. Normal healthy volunteers 21 years of age or older may be eligible for this 40-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age must use a reliable form of birth control other than oral contraceptives ("the pill"). For at least 2 weeks before the study and throughout its duration, study participants may not have any of the following: 1) medications that can affect platelet function (e.g., aspirin, Motrin, Advil, Nuprin, ibuprofen, etc.); 2) alcoholic beverages; 3) grapefruit and grapefruit juice; and 4) all medications except those given by study personnel. On day 1 of the study, subjects take one 500-mg dose of phenytoin at 8:00 A.M.. On an empty stomach. (Subjects fast the night before taking the phenytoin and are allowed to eat breakfast 2 hours after the dose). Blood samples are drawn just before dosing and again at 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72 and 96 hours after the dose. Blood drawn on this first study day is collected through a catheter (small plastic tube) placed in a vein to avoid multiple needlesticks. After the 12-hour sample is collected, the subject goes home and then returns to the clinic for the remaining blood draws, which are taken by direct needlestick. When the blood sampling is completed, subjects begin ginkgo therapy. The NIH Clinical Center provides participants a supply of 60-mg capsules of ginkgo to take twice a day (at 8 A.M. and 8 P.M..) for 4 weeks. At the end of the 4 weeks, subjects are given a second dose of phenytoin as described above and repeat the blood sampling procedure. Subjects continue taking ginkgo during this second phenytoin study.
OTC NCT00267293 ↗ Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever Completed Children Youth and Family Consortium Phase 4 2006-01-01 Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.
OTC NCT00267293 ↗ Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever Completed Penn State University Phase 4 2006-01-01 Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.
OTC NCT01669824 ↗ Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg Completed Bayer 2007-08-01 In this non-interventional one year study, data about overall and particularly gastrointestinal tolerability, indications, cardiovascular risk factors and compliance are collected by basic questionnaires, which are handed out by pharmacists to patients who acquire (in Germany no prescription is needed) Rx (Prescription) or OTC (Over-The-counter) Aspirin protect (enteric coated aspirin) 100 mg and are willing to participate in the study. After 3, 6, 9 and 12 months follow-up questionnaires are sent out. Aim of the study is to get information about safety, usage and compliance under everyday's conditions, because in Germany low-dose aspirin is an OTC product with Rx indication.
OTC NCT02966002 ↗ Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients Terminated University of Michigan Phase 4 2016-04-01 Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop complications many years after their operation. Studies have shown that some of these patients develop an ongoing inflammatory state, which may be the cause of these late complications. Aspirin is a common over the counter anti-inflammatory medication used for many other chronic diseases. This study may help determine if aspirin therapy can limit the inflammation seen in Fontan patients and prevent these late complications.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Mepro-aspirin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000151 ↗ Early Treatment Diabetic Retinopathy Study (ETDRS) Completed National Eye Institute (NEI) Phase 3 1979-12-01 To evaluate the effectiveness of both argon laser photocoagulation and aspirin therapy in delaying or preventing progression of early diabetic retinopathy to more severe stages of visual loss and blindness. To help determine the best time to initiate photocoagulation treatment in diabetic retinopathy. To monitor closely the effects of diabetes mellitus and of photocoagulation on visual function. To produce natural history data that can be used to identify risk factors and test etiologic hypotheses in diabetic retinopathy.
NCT00000152 ↗ Randomized Trial of Beta-Carotene and Macular Degeneration Unknown status National Eye Institute (NEI) Phase 3 1982-04-01 To determine whether 50 mg of beta-carotene taken every other day reduces the risk of developing age-related macular degeneration (AMD) among male U.S. physicians who were aged 40 to 84 in 1982. To investigate the possible relationship of AMD with other antioxidants, including selenium and vitamins A, C, and E. To identify potential risk factors for development of AMD. Possible risk factors include height, systemic hypertension, cardiovascular disease, blood cholesterol, cigarette smoking, iris and skin color, sunlight exposure, body mass index, diabetes, and alcohol intake.
NCT00000157 ↗ Randomized Trial of Aspirin and Cataracts in U.S. Physicians Terminated National Eye Institute (NEI) Phase 3 1982-04-01 To determine whether 325 mg of aspirin taken on -alternate days reduces the risk of developing cataract among male U.S. physicians who were aged 40 to 84 in 1982. To identify potential risk factors for cataract development, such as age, blood pressure, blood cholesterol, height, diabetes, medication use, and history of previous eye trauma or surgery.
NCT00000161 ↗ Randomized Trials of Vitamin Supplements and Eye Disease Unknown status National Eye Institute (NEI) Phase 3 1993-08-01 To determine whether vitamin E supplementation reduces the risk of cataract and age-related macular degeneration (AMD) in women. To determine whether vitamin C supplementation reduces the risk of cataract and AMD in women. To determine whether beta-carotene supplementation reduces the risk of cataract and AMD in women. To determine whether alternate day, low-dose aspirin reduces the risk of cataract and AMD in women. To identify potential risk factors for cataract and AMD including cigarette smoking, alcohol intake, blood pressure, blood cholesterol, cardiovascular disease, height, body mass index, and diabetes.
NCT00000463 ↗ Post Coronary Artery Bypass Graft (CABG) Study Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1987-04-01 To determine the relative effectiveness of moderate versus more aggressive lipid lowering, and of low dose anticoagulation versus placebo, in delaying saphenous vein coronary bypass graft atherosclerosis and preventing occlusion of saphenous grafts of patients with saphenous vein coronary bypass grafts placed 1 to 11 years previously.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Mepro-aspirin

Condition Name

Condition Name for Mepro-aspirin
Intervention Trials
Coronary Artery Disease 179
Acute Coronary Syndrome 85
Stroke 53
Myocardial Infarction 51
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Condition MeSH

Condition MeSH for Mepro-aspirin
Intervention Trials
Coronary Artery Disease 266
Myocardial Ischemia 235
Coronary Disease 217
Infarction 128
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Clinical Trial Locations for Mepro-aspirin

Trials by Country

Trials by Country for Mepro-aspirin
Location Trials
China 457
Japan 319
United Kingdom 300
Canada 295
Italy 226
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Trials by US State

Trials by US State for Mepro-aspirin
Location Trials
New York 135
Texas 129
Florida 121
California 115
Pennsylvania 109
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Clinical Trial Progress for Mepro-aspirin

Clinical Trial Phase

Clinical Trial Phase for Mepro-aspirin
Clinical Trial Phase Trials
Phase 4 525
Phase 3 339
Phase 2/Phase 3 73
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Clinical Trial Status

Clinical Trial Status for Mepro-aspirin
Clinical Trial Phase Trials
Completed 765
Recruiting 236
Unknown status 223
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Clinical Trial Sponsors for Mepro-aspirin

Sponsor Name

Sponsor Name for Mepro-aspirin
Sponsor Trials
National Cancer Institute (NCI) 54
Bayer 50
AstraZeneca 47
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Sponsor Type

Sponsor Type for Mepro-aspirin
Sponsor Trials
Other 2216
Industry 556
NIH 160
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Mepro-Aspirin: Clinical Trials, Market Analysis, and Projections

Introduction to Aspirin and Mepro-Aspirin

Aspirin, a widely used nonsteroidal anti-inflammatory drug (NSAID), has been a cornerstone in the management of pain, inflammation, and cardiovascular diseases for decades. Mepro-Aspirin, a specific formulation of aspirin, is part of this broader category. Here, we will delve into recent clinical trials, market analysis, and projections for the aspirin market, which includes Mepro-Aspirin.

Clinical Trials Update

ASPREE Project

The ASPREE (ASPirin in Reducing Events in the Elderly) project is a landmark study that has significantly contributed to our understanding of aspirin's role in healthy aging. This multi-center, bi-national study involved 19,114 participants, including 2,411 in the U.S. and 16,703 in Australia, all of whom were aged 70+ years (or 65+ years for minorities) and free of dementia, significant physical disability, and known cardiovascular disease at enrollment[1].

  • ASPREE Trial Results: Published in the New England Journal of Medicine in September 2018, the trial's findings have led to revised international aspirin prescribing guidelines.
  • ASPREE-XT Study: This ongoing follow-up observational health study investigates the long-lasting effects of low-dose aspirin on diseases such as cancer and factors contributing to physical and cognitive health in older adults.

ADAPTABLE Trial

The ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) trial is another significant study that compared the effectiveness and safety of two commonly used aspirin doses: 81 mg and 325 mg. This trial involved 15,076 patients with established atherosclerotic cardiovascular disease (ASCVD) and found that aspirin 325 mg was not superior to 81 mg in reducing all-cause death, myocardial infarction, or stroke. The trial also noted similar rates of major bleeding between the two doses[3][4].

Market Analysis

Global Aspirin Market Size and Growth

The global aspirin market is expected to grow steadily over the next decade. Here are some key market projections:

  • Current Market Size: The aspirin market was valued at approximately USD 2.938 billion in 2024[2].
  • Projected Growth: The market is expected to expand at a consistent Compound Annual Growth Rate (CAGR) of 3.8% to reach a valuation of USD 4.236 billion by 2034[2].
  • Regional Market Share: The United States is anticipated to hold a significant share of the global market, with a projected CAGR of 3.9% from 2024 to 2034[2].

Driving Factors

Several factors are driving the growth of the aspirin market:

  • Increasing Chronic Conditions: The rising incidence of chronic conditions such as arthritis, pain, inflammation, renal disorders, cardiovascular diseases, and brain strokes is a major driver[2].
  • Awareness and Public Health Initiatives: Initiatives to spread awareness about myocardial infarction and other cardiovascular diseases are expected to elevate the market scope further[2].
  • Combination Aspirin Drugs: Combination aspirin drugs are leading the market, with a share of about 68% in 2023, due to their effectiveness in managing multiple health issues simultaneously[2].

Market Trends

  • Novel Formulations: Developments in novel formulations, such as hydrogels where aspirin is used as an additive, are expected to increase market growth[5].
  • Healthcare Expenditure: Global healthcare expenditure is on the rise, which is likely to support the demand for aspirin and other pharmaceuticals[2].

Market Projections

Forecast Period

From 2024 to 2034, the aspirin market is projected to experience steady growth driven by various factors:

  • CAGR: The market is expected to grow at a CAGR of 3.8% during this period[2].
  • Valuation: By 2034, the market is anticipated to reach a valuation of USD 4.236 billion[2].

Regional Opportunities

  • United States: Expected to seize a 25.7% global market share in 2024, driven by the increasing need for aspirin to manage chronic pain[2].
  • China: Predicted to provide high growth opportunities due to its large population and increasing healthcare needs[2].

Key Takeaways

  • Clinical Trials: Studies like ASPREE and ADAPTABLE have provided valuable insights into the benefits and risks of aspirin, particularly in older adults and those with cardiovascular diseases.
  • Market Growth: The global aspirin market is expected to grow at a CAGR of 3.8% from 2024 to 2034, driven by increasing chronic conditions and public health initiatives.
  • Regional Focus: The United States and China are key regions for market growth, with the U.S. expected to hold a significant market share.

FAQs

What is the ASPREE project, and what are its key findings?

The ASPREE project is a long-term, multi-center study focusing on the effects of low-dose aspirin in healthy older adults. Key findings include revised international aspirin prescribing guidelines and ongoing research into the long-lasting effects of aspirin on various diseases.

What was the primary goal of the ADAPTABLE trial?

The ADAPTABLE trial aimed to evaluate the effectiveness and safety of aspirin 81 mg compared to 325 mg among patients with established atherosclerotic cardiovascular disease (ASCVD).

What is driving the growth of the global aspirin market?

The growth is driven by increasing chronic conditions such as arthritis, pain, inflammation, and cardiovascular diseases, as well as public health initiatives and the development of novel formulations.

What is the projected market size of the aspirin market by 2034?

The aspirin market is expected to reach a valuation of USD 4.236 billion by 2034, growing at a CAGR of 3.8% from 2024 to 2034.

Which regions are expected to provide high growth opportunities for the aspirin market?

The United States and China are predicted to provide significant growth opportunities, with the U.S. expected to hold a 25.7% global market share in 2024.

Sources

  1. ASPREE USA: "Home - Studying the effect of aspirin and other factors on health in older adults."
  2. Future Market Insights: "Aspirin Drug Market Size, Share & Forecast to 2034."
  3. FDA: "Framework for FDA's Real-World Evidence Program."
  4. American College of Cardiology: "Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness - ADAPTABLE."
  5. Verified Market Research: "In-Depth Industry Outlook: Aspirin Market Size & Forecast."
Last updated: 2025-01-01

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